The present invention relates to the field of protective devices for medical apparatus. In particular, the present invention relates to a protective device for use on the connector ends of catheters used with radiation source delivery devices used in intravascular radiation therapy.
Currently, many intravascular procedures require insertion of catheters into the vessel of a patient to provide a selected treatment to a target area of the vessel. For example, a patient may require a balloon angioplasty procedure to dilate a vessel narrowed by atherosclerosis. This procedure is performed by inserting a balloon dilation catheter into the vessel of a patient, positioning the balloon dilation segment of the catheter within the constricted portion of the vessel, dilating the vessel, and then removing the dilation catheter from the patient. Often this procedure is followed by radiation therapy to prevent restenosis, or renarrowing, of the vessel area that was dilated by the angioplasty procedure.
Some radiation therapy procedures are also intravascular. For example, a prescribed dose of radiation may be administered using a catheter connected to a radiation source delivery device. The catheter typically has a treatment segment at the distal end that is positioned within the dilated vessel of the patient. The treatment segment receives a radiation source delivered through the lumen of the catheter. A connector located at the proximal end of the catheter attaches to the radiation source delivery device, such as an afterloader. In some instances, the connector may simply attach externally to the radiation delivery device to form the connection, for example, by attaching to a connection port. In other instances, the connector may be inserted into the radiation delivery device to form the connection, for example, by inserting into a connection port in a key-like manner.
Generally, the catheter is first positioned within the dilated portion of the vessel and then the connector is attached to the radiation source delivery device. The radiation source delivery device advances a radiation source through the catheter to the treatment segment and delivers the prescribed radiation dose to the vessel. After delivery of the prescribed dose, the radiation source delivery device withdraws the radiation source from the catheter, the catheter is disconnected from the radiation source delivery device, and then the catheter is withdrawn from the patient.
Intravascular procedures which utilize catheters, such as those described above, are often carried out under low light conditions to aid in positioning the catheters within the vessel. Typically, catheter positioning is performed using radioimagery methods, such as fluoroscopy, in which the location of radio-opaque markers on the catheter are used to position the catheter within the vessel. Further, during insertion of the catheter into the patient, there is frequently blood and other fluids, such as saline, that are present in the procedure area and on the gloves of the medical team. Under these conditions, it is possible for the catheter connector to become contaminated by blood or fluids prior to attachment to the radiation source delivery device.
As the radiation source delivery device is nonsterile and is for multiple use, any contamination of the device requires that the device be removed from operation and cleaned prior to continued use. Cleaning and service of the radiation source delivery device can be expensive and time consuming and removes a needed system from use by other patients. If the catheter connector becomes contaminated and is then attached to the radiation source delivery device, there is the possibility of the contaminants entering the radiation source delivery device and causing a malfunction during the procedure. Some medical teams currently wrap a towel around the catheter connector prior to attachment to the radiation source delivery device to protect the connector and the radiation source delivery device from contamination. However, under the low light conditions and in limited operating space, it becomes time consuming and cumbersome to ensure the catheter connector remains covered during catheter positioning within the patient.
Thus, a need exists to help prevent contamination of the radiation source delivery device by the connector that is easy to use and does not encumber the intravascular procedure.
The present invention includes a peel-away protective cover to help prevent contamination of a connector prior to attachment to a radiation source delivery device. The protective cover comprises a top sheet and a bottom sheet that are sealed together to create a protective pouch within which a connector may be positioned. The top sheet and bottom sheet may be peeled away in a proximal to distal direction in order to expose the connector for attachment to a radiation source delivery device. The proximal to distal peel-away directs any contaminants present on the protective cover away from the exposed connector. In one embodiment, the protective cover may be completely peeled away from the connector. In another embodiment, the protective cover may be partially peeled away so that the separated top and bottom sheets of the protective cover shield the connection to the radiation source delivery device.